In 2017 the United States Food and Drug Administration (FDA) convened a Logical Observation Identifiers Names and Codes (LOINC®) Working Group to make recommendations to the Agency regarding the forthcoming mandate to submit LOINC codes to regulators. This Working Group was a collaborative effort among the FDA, National Cancer Institute, National Library of Medicine, Regenstrief Institute and CDISC. Though the effective date for the LOINC mandate has been moved from March 2018 to March 2020, the FDA has now made available a final version of the Working Group's recommendations as part of a recent update to its Study Data Standards Resources / Research and Collaborations webpage.
This recommendations document is not guidance; rather it is a set of recommendations from the Working Group that the FDA may or may not choose to take under advisement for future LOINC requirements. As described within the recommendations document, CDISC-compliant submissions currently support the inclusion and submission of LOINC codes as part of the laboratory (LB) domain. The CDISC community is encouraged to review the recommendations from the Working Group and continue following FDA guidance that is published as updates to the Study Data Technical Conformance Guide (TCG).